MAUDE Adverse Event Report: AESCULAP AG CAIMAN DISP.INSTR.ARTICULAT.D5/360MM; BIPOLAR TECHNOLOGIES

Model Number	PL741SU
Medical Device Problem Code	Material Fragmentation (1261)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	01/26/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
Event or Problem Description
It was reported to aesculap ag that a caiman 5 articulating vessel sealer (part # pl741su) was used during a laparoscopic surgerical procedure performed on (b)(6) 2021.According to the complainant, while using the clamp, at the articulation, the plastic sheath detached.An additional medical intervention was necessary.Additional information was not provided.Additional information has been requested but not yet received as of this report.Additional patient information is not available.The adverse event is filed under aag reference (b)(4).
Additional Manufacturer Narrative
Patient harm was updated to no patient harm.Changed h6 / impact code : no health consequence or impact.Investigation results: visual investigation: the jaw of the device was investigated visually.Except the blood soiling and the damaged shrink hose, we found no further external damage.Then we checked the mechanical function.The clamping and the cutting function worked well.Batch history review: the device quality and manufacturing history records have been checked for the available lot number and were found to be according to our specifications valid at the time of production.Review of the complaint history revealed that one similar complaint has been filed against products from this batch number out of the same clinic.The review of risk assessment revealed that the overall risk level (severity x probability of occurrence) according to din en iso 14971 is still acceptable.Conclusion and measures / preventive measures: based upon the investigation results a clear root cause conclusion cannot be drawn.There is no indication for a material-, manufacturing- or design-related failure.Based upon the investigations results a capa is not necessary.
Event or Problem Description
According to new information available no patient harm occured.

• Brand Name: CAIMAN DISP.INSTR.ARTICULAT.D5/360MM
• Common Device Name: BIPOLAR TECHNOLOGIES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 11373265
• Report Number: 9610612-2021-00101
• Device Sequence Number: 11050596
• Product Code: GEI
• UDI-Device Identifier: 04046964694158
• UDI-Public: 4046964694158
• Combination Product (Y/N): N
• Initial Reporter Country: FR
• PMA/510(K) Number: K151696
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: company representative,foreig
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/30/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 10/25/2022
• Device Model Number: PL741SU
• Device Catalogue Number: PL741SU
• Device Lot Number: 52643550
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/18/2021
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/28/2021
• Supplement Date Received by Manufacturer: 03/15/2021
• Initial Report FDA Received Date: 02/24/2021
• Supplement Report FDA Received Date: 04/07/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention