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Mat# sp8343 lot# unknown.It was reported by the customer that patient injured during trial of product, no bd product malfunctioned.Verbatim: patient injury when trialing.21feb2023 additional information: 1.What was the operation/procedure that was being performed? the case was a small bowel obstruction.2.What was the outcome/injury to the patient? small puncture to the bowel.3.Which part of the device malfunctioned or was faulty, i.E.Sp94, sp83, sp8343? none of the products (sp94, sp83, sp8343) malfunctioned.4.When was the defect found? before use, during use, or after use? there is not a defect.5.What are the lot numbers for these devices? unsure at this time.6.Can you please send all parts of the instrument for evaluation? yes.7.Do you have photos of the reported issue on the instrument? no issue to instrument in regards to this case, i just want to elaborate slightly.There was no malfunction of our instrument that caused this injury.No bends or screws popping off or anything like that.01mar2023 additional information: patient had a follow up surgery at another facility with partial resection to repair damage.
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Mat# sp8343 lot# unknown.It was reported by the customer that patient injured during trial of product, no bd product malfunctioned.Verbatim: patient injury when trialing.21feb2023 additional information: 1.What was the operation/procedure that was being performed? the case was a small bowel obstruction.2.What was the outcome/injury to the patient? small puncture to the bowel.3.Which part of the device malfunctioned or was faulty, i.E.Sp94, sp83, sp8343? none of the products (sp94, sp83, sp8343) malfunctioned.4.When was the defect found? before use, during use, or after use? there is not a defect.5.What are the lot numbers for these devices? unsure at this time.6.Can you please send all parts of the instrument for evaluation? yes.7.Do you have photos of the reported issue on the instrument? no issue to instrument.In regards to this case, i just want to elaborate slightly.There was no malfunction of our instrument that caused this injury.No bends or screws popping off or anything like that.01mar2023 additional information: patient had a follow up surgery at another facility with partial resection to repair damage.
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Follow up (b)(6).Upon receipt, the complaint samples received a visual examination and a functional check.A total of 6 modular devices which assemble into two distinct laparoscopic instruments were received, (2) sp83 shafts, (2) sp94 handles, an sp8344 insert, and an sp8343 insert.The sp83 shafts had the following markings: snowden pencer, usa, ce0123, a 2d udi barcode, and b22.The sp94 handles had the following markings: sp94, a date code, snowden pencer, ce0123, and usa.The sp8344 insert had the following markings: snowden pencer, ce0123, usa, sp8344 and a16.The sp8343 insert had the following markings: (b)(6), and k18.No evidence was found that any of the devices were not authentic.Upon visual examination and functional check, a complaint failure mode was not confirmed.Both sp94 handles were functionally checked with all 4 distinct combinations of sp83 shafts and both inserts.The modular assemblies were inspected per the requirements of 07-0926 ¿functional inspection of modular instrument assemblies work process¿.The sp94 handles were both found to: toggle into ratchet defeat mode without the ratchet catching, that the ratchet releases when depressed downward, the handle actuates fully open without assistance, the jaws open and close fully as the handle actuates open and closed, the ratchet engages when the ratchet lever is not in the defeat position or depressed, at least 3 ratchet teeth remain after the jaws are closed, the rotation knob stops on all 8 detent positions, the handle, knob, flush port, and jaw are all in alignment, the shaft and insert are easily removed when the knob buttons are squeezed and securely held in place when the knob buttons are not.The knob buttons fully extend when the handle is separated from the shaft and insert, the knob buttons operate fully and smoothly, and the front and back halves of the knob show no signs of separation.No parts of any of the 6 devices are missing, and no visual indications of material damage that would pose an increased risk of injury to a patient was observed on the jaws or any other device component.The only way for the jaw/shaft to slip during surgical use is if the knob buttons did not pop in place when the shaft and insert were fed into them.The only other customer assembly error of any relevance would be if the shaft and insert were locked into the knob properly, but the handle was not in the fully opened state at the time of assembly, causing the proximal actuating rod ball to miss its mating feature in the handle thumb bow, however, this error would be quickly noticed as it would result in the handle actuation having zero effect on jaw actuation.As stated by the customer, no device malfunction occurred.A review of the complaint history log was performed, no other complaints for the same combination of product codes and date codes, with a failure mode that could potentially be related to the mdr event were identified.Additionally, the device history records (dhr) for all the devices were reviewed, no non-conformances were identified which could have contributed to the complaint failure mode.Based on: 1) the absence of a stated complaint failure mode or malfunction by the operator 2) the absence of a functional issue that could have contributed to an mdr event for any of the 6 devices received, 3) the absence of complaints from other customers for the same combination of product codes and date codes for a failure mode that could have contributed to an mdr event, and 4) the absence of a non-conformance in the manufacturing record (dhr) for all 6 devices, the complaint failure mode is not confirmed, and the most probable root cause could not be determined.H3 other text : see h10.
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