MAUDE Adverse Event Report: AESCULAP AG INSULATED OUTER TUBE 5/5MM 310MM; MONOPOLAR REUSABLE INSTRUMENTS

Model Number	PM973R
Medical Device Problem Codes	Material Disintegration (1177); Material Fragmentation (1261)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/04/2021
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported to aesculap ag that an insulated outer tube 5/5mm 310mm (part # pm973r) was used during a laparoscopic procedure performed on (b)(6) 2021.According to the complainant, during the procedure, the grasper splintered inside patient.Reportedly, the surgeon managed to retrieve some, but not all, fragments.The complaint device was returned to the manufacturer for evaluation.A fragment remained inside the patient.An addition medical intervention was required.Although requested, additional information has not been made available.The adverse event is filed under aag reference (b)(4).Involved components: po959r - monopolar handle with ratchet - batch unknown.
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Additional Manufacturer Narrative
Investigation results: visual investigation: the outer tube of the instrument was splintered at the front end.The splinters were not enclosed.A digital camera was used for test and analysis of the equipment.At first a visual inspection of the instrument shaft was made.Here it was found that the front end was bent and the insulation tube was splintered.In next step, it was tried to pull the instrument out of the isolation tube.This was not possible even with the help of pliers or a hammer.Batch history review: the review of risk assessment revealed that the overall risk level (severity 4(5) x probability of occurrence 2(5)) 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.

• Brand Name: INSULATED OUTER TUBE 5/5MM 310MM
• Common Device Name: MONOPOLAR REUSABLE INSTRUMENTS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer (Section G): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• Manufacturer Contact: christian von der grün ; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 12910678
• Report Number: 9610612-2021-00706
• Device Sequence Number: 4946745
• Product Code: GEI
• UDI-Device Identifier: 04038653183715
• UDI-Public: 4038653183715
• Combination Product (Y/N): N
• Initial Reporter Country: UK
• PMA/510(K) Number: K001330
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/02/2022

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 Model Number: PM973R
• Device Catalogue Number: PM973R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2021
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/04/2021
• Supplement Date Received by Manufacturer: 02/01/2022
• Initial Report FDA Received Date: 12/01/2021
• Supplement Report FDA Received Date: 03/02/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Unknown
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: PO959R - LOT UNKNOWN.; PO959R.
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown