MAUDE Adverse Event Report: AESCULAP AG JAW INS.BIP.MARYLAND DISS.FEN.5/310MM; ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES

Model Number	PM438R
Medical Device Problem Code	Break (1069)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/12/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Manufacturing site evaluation: investigation on-going.Should relevant additional information / investigation results become available, a supplemental medwatch report will be submitted.
Event or Problem Description
It was reported to aesculap ag that a jaw ins.Bip.Maryland diss.Fen.5/310mm (part # pm 438r) was used during a procedure performed on (b)(6) 2021.According to the complainant, during the procedure, forcep breakage occurred and fragments were left in patient.Reportedly, the nurses found that the forceps were not inact after use.The complaint device has not been returned to the manufacturer for evaluation.No patient complications were reported as a result of the event.Although requested, additional information has not been made available.The malfunction is filed under aag reference cc (b)(4).
Additional Manufacturer Narrative
Correction / additional information: b5: patient injury had occurred and patient harm was reported as "the fragments reamined in situ".Investigation results: as of the date of this report the complaint product was not provided for investigation.Therefore, a thorough investigation is not possible.Batch history review: due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.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.In the event that the complaint product will be provided for investigation in the future, an update of this report will be provided unsolicited.Based upon the investigations results a capa is not necessary.
Event or Problem Description
Correction / additional information: patient injury had occurred and patient harm was reported as "the fragments reamined in situ".Added involved components.The fragment remained in situ.Involved components: pm450r - handle for bipolar instruments - lot unknown.Pm973r - insulated outer tube 5/5mm 310mm - lot unknown.

• Brand Name: JAW INS.BIP.MARYLAND DISS.FEN.5/310MM
• Common Device Name: ELECTROSURGICAL, CUTTING & COAGULATION & ACCESSORIES
• 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: 12975779
• Report Number: 9610612-2021-00770
• Device Sequence Number: 4217080
• Product Code: GEI
• UDI-Device Identifier: 04038653322862
• UDI-Public: 4038653322862
• Combination Product (Y/N): N
• Initial Reporter Country: HK
• 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): 03/14/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: PM438R
• Device Catalogue Number: PM438R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 11/18/2021
• Supplement Date Received by Manufacturer: 03/08/2022
• Initial Report FDA Received Date: 12/10/2021
• Supplement Report FDA Received Date: 03/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• 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: PM450R - LOT UNKNOWN; PM973R - LOT UNKNOWN
• Patient Sex: Unknown